CLASS I Device recall · Reported 12 Feb 2020 · FDA Enforcement Report
Stellar, Non-invasive/invasive ventilators recalled by ResMed
ResMed is recalling ResMed Stellar, Non-invasive/invasive ventilators, distributed in 9 states. The recall was initiated on 12 Dec 2019 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0915-2020
- FDA event ID
- 84551
- Recalling firm
- ResMed, Bella Vista, N/A
- Classification
- Class I
- Status
- Completed
- Recall initiated
- 12 Dec 2019
- FDA classified
- 6 Feb 2020
- Reported
- 12 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 12 Dec 2019 | Recall initiated by company | |
| 6 Feb 2020 | Classified by FDA | +56 days |
| 12 Feb 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Where it was distributed
U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT
ConnecticutFloridaGeorgiaIllinoisMassachusettsMontanaPennsylvaniaTennesseeVirginia
Questions about this recall
Is Stellar, Non-invasive/invasive ventilators recalled?
Yes. ResMed recalled Stellar, Non-invasive/invasive ventilators on 12 Dec 2019. The recall is Class I and its status is Completed. Recall number Z-0915-2020.
Why was it recalled?
Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch.
Which lots are affected?
Serial Number Range: 20160123307 to 22171057208
Where was it sold?
U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from ResMed
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | AirFit N20 Nasal Mask and User Guide recalled by ResMed | ResMed | Other | Nationwide |
| Device | CLASS I | AirFit F30i Full Face Mask and User Guide recalled by ResMed | ResMed | Other | Nationwide |
| Device | CLASS I | AirFit F20 Full Face Mask and User Guide recalled by ResMed | ResMed | Other | Nationwide |
| Device | CLASS I | AirFit N10 Nasal Masks and User Guide recalled by ResMed | ResMed | Other | Nationwide |
Other CPAP & Ventilators recalls
All 551| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |
| Device | CLASS I | Giraffe Stand-alone Infant Resuscitation System recalled by Datex-Ohmeda | Datex-Ohmeda | Device Malfunction | WI |